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FDA NDA · NDA211150

WAKIX

pitolisant hydrochloride

Sponsor: HARMONY

APPLICATION
NDA211150
TYPE
NDA
ORIGINAL APPROVAL
2019-08-14
LATEST ACTION
2026-02-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

WAKIX · ReferencePrescription
PITOLISANT HYDROCHLORIDE EQ 4.45MG BASE · TABLET · ORAL
WAKIX · ReferencePrescription
PITOLISANT HYDROCHLORIDE EQ 17.8MG BASE · TABLET · ORAL

Approval history

2026-02-13Efficacy · Supplement 6 · priority — Letter ↗AP
2025-05-23Labeling · Supplement 7 · standard — Letter ↗AP
2024-06-21Efficacy · Supplement 5 · priority — Label ↗AP
2022-12-22Labeling · Supplement 3 · standard — Letter ↗AP
2020-10-13Efficacy · Original · priority — Label ↗AP
2019-08-14Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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